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510(k) K991430

SMARTPREP CENTRIFUGE SYSTEM by Harvest Technologies, LLC — Product Code JQC

K991430 is an FDA 510(k) premarket notification submitted by Harvest Technologies, LLC for the device "SMARTPREP CENTRIFUGE SYSTEM". The FDA issued a decision of Substantially Equivalent on May 28, 1999. The device falls under product code JQC (Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use), a Class I device regulated under 21 CFR 862.2050. Harvest Technologies, LLC has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1999
Date Received
April 26, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Device Class
Class I
Regulation Number
862.2050
Review Panel
CH
Submission Type

Other clearances by Harvest Technologies, LLC

  • K121005 — ADIPREP ADIPOSE TRANSFER SYSTEM (September 21, 2012)
  • K103340 — SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM (December 6, 2010)
  • K052925 — SMARTPREP2 CENTRIFUGE SYSTEM (January 4, 2006)
  • K043261 — HARVEST GRAFT DELIVERY SYRINGE (March 11, 2005)
  • K020252 — SMARTJET GRAFTING LIQUID APPLICATOR, MODELS SK/S & LK/2 (April 5, 2002)
  • K011032 — SMARTJET BONE GRAFT LIQUID APPLICATOR (SPRAY TIP), MODEL SK/S, SMARTJET BONE GRA (July 3, 2001)
  • K000456 — HARVEST TECHNOLOGIES DUAL LIQUID APPLICATOR, MODEL SK/S: HARVEST DUAL LIQUID AP (June 1, 2000)
  • K983022 — SMARTCELL PROCESSING SYSTEM (April 2, 1999)

Other clearances for product code JQC

  • K183205 — PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiol (May 30, 2019)
  • K103340 — SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM (December 6, 2010)
  • K081345 — AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY) (July 10, 2008)
  • K071934 — MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT (October 11, 2007)
  • K070666 — GENESISCS COMPONENT CONCENTRATING SYSTEM (June 20, 2007)
  • K052925 — SMARTPREP2 CENTRIFUGE SYSTEM (January 4, 2006)
  • K042473 — COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM (November 19, 2004)
  • K024080 — SECQUIRE CELL SEPARATOR (July 2, 2003)
  • K030340 — AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129) (April 11, 2003)
  • K030555 — GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A (April 11, 2003)

FDA data resources